September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in research and obtaining regulatory approval in Canada, followed from Canada’s commitments under CETA (the Canada-European Union Comprehensive Economic and Trade Agreement, see our earlier article here). As we look back on the previous year, we will recap how the regime works and provide an update on CSPs granted and rejected to date.
What is a CSP?
A CSP grants the holder (which can notably be a company other than the market authorization holder/related company) and their legal representatives the same rights granted by the patent set out in the CSP, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the CSP, by itself or in addition to any other medicinal ingredient. A CSP can be granted for both small molecule (human and veterinary) and human biologic drugs. The rights cannot be enforced against uses for export.
A CSP takes effect on the expiry of the patent term. The CSP term is calculated by subtracting the patent filing date from the notice of compliance (NOC) issuance date, minus five years, to a maximum of two years. An NOC is the authorization for sale in Canada.
CSPs can be enforced both within and outside actions under Canada’s patent linkage regulations- the Patented Medicines (Notice of Compliance) Regulations (see our companion article here). Once issued, if eligible, a CSP will be automatically added to the Patent Register by Health Canada for purposes of patent linkage litigation.
How to obtain a CSP
In very general terms, a CSP may be granted on application to Health Canada if:
- the patent contains a claim for:
- the medicinal ingredient or combination of all the medicinal ingredients in a drug, including in product-by-process form or
- a use of the medicinal ingredient or combination of all the medicinal ingredients in a drug,
- the above drug is approved by Health Canada via a NOC,
- the NOC:
- issued on or after September 21, 2017,
- is the first approval for the drug at issue (for the single active or combination, as the case may be) or a prescribed variation thereof,
- issued from a submission filed within twelve months of the filing of the first application for marketing approval of the medicinal ingredient or combination in the U.S., Europe or any member country thereof, Japan, Switzerland and Australia (the transitional provision has now expired).
- the CSP application, including the current $9,192 fee, is filed with Health Canada within 120 days of the later of the date of grant of the NOC and patent grant date,
- no prior CSP has issued for the medicinal ingredient or combination of medicinal ingredients or a prescribed variation thereof, and
- there is no conflict with a competing application, or the conflict has been resolved.
A chart comparing CSPs to European Supplementary Protection Certificates is here.
Approvals, Rejections, Applications in Progress
As of September 21, 2018, Health Canada had granted thirteen CSPs for drugs for human use and one for a veterinary drug; two applications were pending. Health Canada had rejected three applications on the following bases:
- REBINYN (coagulation factor ix (recombinant)), as the medicinal ingredient had “post-translational modification(s)” to medicinal ingredients in previously approved drugs, namely pegylation and different glycosylation patterns,
- MAVIRET (glecaprevir/pibrentasvir), as the NOC issued before September 21, 2017 and the patent claims specify only one medicinal ingredient (see Guidance document revision below) whereas the drug at issue includes a combination of medicinal ingredients, and
- SHINGRIX, as the patent did not include an eligible claim: it includes formulation claims to the antigen and adjuvant.
GlaxoSmithKline has brought an application for judicial review of the rejection of the SHINGRIX application. One of the issues raised is whether both the antigen and adjuvant in SHINGRIX are medicinal ingredients.
Regime in context
In addition to patents and CSPs, small molecule (human and veterinary) and human biologic drugs approved in Canada that meet the definition of an “innovative drug” are also protected by data protection (see Health Canada guidance here and Register of Innovative Drugs). An innovative drug is “a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.” A subsequent manufacturer seeking approval on the basis of a direct or indirect comparison to the innovative drug cannot file its submission until 6 years after the innovator drug’s first approval and cannot receive approval until 8 years after such approval, or 8.5 years if the pediatric extension is granted.
In assessing the value of any potential CSP, its expiry relative to data protection expiry is key.
The CSP regime was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the life cycle planning, including in view of the one-year regulatory filing deadline. Prosecution of the patent should also be co-ordinated to ensure, if possible, that the patent grants before the NOC issues, as this may govern entitlement to the CSP in the event of a conflict with a competing application for a CSP.
- Text of CETA Article 20.27: Sui generis protection for pharmaceuticals
- Patent Act Sections 104-134: Supplementary Protection for Inventions — Medicinal Ingredients (per Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act, s. 59)
- Certificate of supplementary protection regulations (version with RIAS is here) Register of Certificates of Supplementary Protection and Applications (with links to application forms and payment details)
- Health Canada Guidance (revised on September 4, 2018, including section 2.2.8 to indicate Health Canada’s view that for a combination claim to be eligible, “[e]ach of the medicinal ingredients must be specified in the claim.” A medicinal ingredient can be specified for example by structure or sequence).